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<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>Hi Catherine,</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>While I agree that the proposed UW rule has many flaws, it
is certainly a step in the right direction. We are lucky enough, in this
country, to be afforded an opportunity to comment on the proposal and hopefully
EPA will take note of the inconsistencies when making their first set, of
probably several, revisions. Barring my tendency to procrastinate, I plan
to detail our concerns and be part of the process as one small voice of a
broader dialog.</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>One example of blatant inconsistency in the proposal is
that it excludes contaminated cleanup material and PPE from the UWR. So we
are going to manage hazardous waste pharmaceuticals as Universal waste, but PPE
(gloves and gowns) must be managed under full RCRA? So many comments
have been made to date supporting the proposal on it's face value without
reading the fine print. The industry needs to get this right the first
time around because getting it changed after the fact could take forever (or
longer).</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>To the best of my knowledge, RCRA doesn't list ANY
pharmaceuticals in the regulation, but rather commercial chemical products that
when present -as the sole active ingredient- causes a pharmaceutical product to
be "listed" hazardous waste when discarded. The EPA demonstrates this
in the preamble to their proposal (see footnote #26 of the FR). They
explain that warfarin (P001) is used in at least 6 drugs, and Melphalan (U150)
is used in 5 products. That's 11 listed drugs resulting from just two of
the 31 RCRA listed wastes. This is even more true when addressing
"characteristic" wastes: Alcohol is a single product with a waste code of
D001. But how many pharmaceutical formulations are there with greater than
24% alcohol? Not many perhaps, but the quantity is certainly greater than
one. Then we have NIOSH, ASHP, OSHA and a host of others who make
recommendations to manage additional drugs, yet are powerless to impose
regulating them. Too often we encounter hospitals who post the RCRA
P&U lists on the wall and call it a program. It's EPA's fault for not
conveying it's expectations in a clear and concise manner that the general
public can understand. Perhaps the proposed UW rule is a first step
in that direction.</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>As to the benefits, or lack thereof, of including
pharmaceuticals in the UWR there are more than are immediately
recognizable. Allowing "handlers" to consolidate volumes of waste from
several other handlers without full Part B RCRA permit requirements saves
generators tons of money... and make no mistake, money is among the primary
obstacles to compliance, second only to lack of education or understanding of
the regs. Since the passage of the Universal Pharmaceutical Waste (UPW)
regulation in Florida in April '07, we have experienced a cost reduction to the
generator of over 85% with an even greater increase in compliance. As
other states follow suit, compliance will increase along with volumes and
competition among waste handlers will drive prices down even further. The
downside to making it too easy are the host of unintended consequences of not
properly vetting an individual or company who intends to become an "intermediate
handler", as it were.</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=734004715-13022009><FONT face=Arial
color=#0000ff size=2>Getting back to the subject at hand which is the article
that Deborah posted, the entire premise of the article is flawed. But what
really caught my eye was this comment: "<FONT color=#000000 size=3>Once
listed as a universal waste, substances can be more easily recycled and disposed
of in landfills, rather than in the wastewater stream</FONT> ". I nearly
sprayed coffee all over the computer when I read that. It's this
kind of misinformation that take on lives of their own. Perhaps a letter
to the editor is warranted.</FONT></SPAN></DIV>
<DIV><SPAN class=734004715-13022009><FONT face=Arial color=#0000ff
size=2></FONT></SPAN> </DIV>
<DIV><SPAN class=734004715-13022009><FONT face=Arial color=#0000ff size=2>Best
Regards,</FONT></SPAN></DIV>
<DIV><SPAN class=734004715-13022009><FONT face=Arial color=#0000ff
size=2>Barry</FONT></SPAN></DIV>
<DIV><SPAN class=734004715-13022009><FONT face=Arial color=#0000ff
size=2></FONT></SPAN> </DIV>
<DIV><SPAN class=734004715-13022009><!-- Converted from text/rtf format -->
<P><FONT face="Century Gothic" color=#008000 size=2>Clean Fuels of Florida,
Inc.</FONT> <BR><FONT face="Century Gothic" color=#008000 size=2>D. Barry
Fernandez, President</FONT> <BR><FONT face="Century Gothic" color=#008000
size=2>2635 NE 4th Avenue</FONT> <BR><FONT face="Century Gothic" color=#008000
size=2>Pompano Beach, FL 33064</FONT> <BR><FONT face="Century Gothic"
color=#008000 size=2>Tel: 954-791-9588</FONT> <BR><FONT
face="Century Gothic" color=#008000 size=2>Fax: 954-791-9366</FONT> <BR><FONT
face="Century Gothic" color=#008000 size=2>Cell: 305-216-4941</FONT>
<BR><FONT face="Century Gothic" color=#008000 size=2>Toll Free:
800-725-8711</FONT> <BR><A href="mailto:barry@clean-fuels.net"><U><FONT
face="Century Gothic" color=#0000ff size=2>barry@clean-fuels.net</FONT></U></A>
<BR><A href="http://www.clean-fuels.net/"><U><FONT face="Century Gothic"
color=#0000ff size=2>www.clean-fuels.net</FONT></U></A> </P></SPAN></DIV>
<DIV dir=ltr align=left><BR></DIV>
<DIV class=OutlookMessageHeader lang=en-us dir=ltr align=left>
<HR tabIndex=-1>
<FONT face=Tahoma size=2><B>From:</B> Catherine Zimmer [mailto:zimme053@umn.edu]
<BR><B>Sent:</B> Thursday, February 12, 2009 10:17 AM<BR><B>To:</B>
DeBiasi,Deborah<BR><B>Cc:</B>
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> Re: [Pharmwaste] Industry
Urges EPA To Align Pharmaceutical WasteRules With DEA<BR></FONT><BR></DIV>
<DIV></DIV>Hi Deborah and all,<BR>I don't know who wrote this article, but their
are errors in their assertions and the responses from the parties cited indicate
ignorance with the proposed rule. First, we all know pharmaceuticals are
not "recycled". And this proposed rule will not "recycle" more
pharmaceuticals, nor does it do anything to conserve resources or reduce
waste. The proposed pharmaceutical universal waste rule only covers RCRA
hazardous waste which is a mere 31 pharmaceuticals out of a host of
thousands. There is no guaranty with this rule that all waste
pharmaceuticals will now be managed appropriately and not discarded to the
wastewater or landfills. The hazardous waste pharmaceuticals still must be
managed as hazardous waste, the rule proposes some of the management criteria
are reduced. <BR><BR>There are numerous flaws in the proposed rule and it
is but a small band aid on the much larger issues of pharmaceutical waste and
RCRA--both of which need to be addressed in a more comprehensive and thoughtful
fashion. <BR><BR><BR><PRE class=moz-signature cols="65">Catherine Zimmer
Health Care Specialist
Minnesota Technical Assistance Program
University of Minnesota
612.624.4635, 800.247.0015
<A class=moz-txt-link-freetext href="http://www.mntap.umn.edu">http://www.mntap.umn.edu</A>
Helping Minnesota businesses maximize resource efficiency, increase energy efficiency, reduce costs, and prevent pollution</PRE><BR><BR>DeBiasi,Deborah
wrote:
<BLOCKQUOTE cite=mid:6C097DA58429B743A67070F98BE73A37040D1692@deqex01.deq.local
type="cite"><PRE wrap="">
Daily News from InsideEPA.com - Wednesday, February 11, 2009
Industry Urges EPA To Align Pharmaceutical Waste Rules With DEA
EPA is giving state regulator and industry groups additional time to
comment on its plan to ease pharmaceutical waste regulations amidst
calls from some groups that the agency should work to coordinate its
proposal with another drug disposal rule being planned by the Drug
Enforcement Agency (DEA).
The agency on Nov. 20 released the proposal to add pharmaceuticals to a
list of wastes eligible for regulation under its Universal Waste Rule,
which is generally less stringent than the agency's strict rules for
hazardous wastes under the Resource Conservation & Recovery Act (RCRA).
EPA is developing the rule as one of several measures intended to limit
disposal of unused pharmaceuticals in the wastewater stream. Once listed
as a universal waste, substances can be more easily recycled and
disposed of in landfills, rather than in the wastewater stream.
In comments submitted to EPA, industry groups said they were generally
supportive of the proposal but they, along with state regulators, said
they would be unable to fully evaluate the proposal's impacts by the
original Feb. 2 comment deadline.
In a Feb. 3 Federal Register notice, EPA announced it was extending the
comment period for an additional month -- until March 4 -- a move that
appears to largely address the groups' requests, although some had asked
that the comment period be extended by 45 or 60 days. The move is also
consistent with an Obama White House memo ordering all federal agencies
to extend comment deadlines on rules the Bush administration proposed
during its final days in office.
The proposed rule, which applies to pharmacies, hospitals, doctor's
offices and other medical facilities, is intended to "facilitate better
management of pharmaceutical wastes by streamlining the generator
requirements and encouraging generators of hazardous pharmaceutical
wastes to manage them under the provisions of the Universal Waste Rule,
which ensures that these hazardous pharmaceutical wastes are properly
disposed of and treated as hazardous wastes," according to EPA.
In Jan. 22 comments (see attached), the Environmental Technology Council
(ETC), a trade association that represents the commercial hazardous
waste industry, says it "strongly agree[s with EPA] that hazardous
pharmaceutical wastes are one of the most widely mismanaged waste
streams under RCRA today." ETC says that "[l]ike the Agency [it is]
hopeful that health care facilities will decide to manage both hazardous
and non-hazardous pharmaceuticals in the universal waste program, and
thus facilitate better management and remove substantially greater
volumes of these materials from the municipal waste stream."
In order to determine whether the proposal will achieve this goal, ETC
is "reviewing waste management information on the nature, percentage
and/or volumes of wastes collected from health care facilities," a
process it says it would have been unable to complete by Feb. 2. The
group is also "attempting to obtain information from members'
pharmaceutical take-back programs and household hazardous waste
collection programs to gauge the potential for redirecting
pharmaceutical wastes into the [universal waste] system."
In addition, ETC notes that on Jan. 21 the DEA issued an advanced notice
of proposed rulemaking in which it is "seeking options for safe and
responsible disposal of dispense controlled substances in a manner
consistent with the Controlled Substances Act and it's implementing
regulations," according to the notice. DEA in the advanced notice is
"soliciting information on the disposal of controlled substances
dispensed to individual patients, also defined as ultimate users, as
well as long term care facilities" in "response to concerns raised by
individuals, public and private organizations, the healthcare industry,
and the law enforcement community."
ETC says that "[o]ften waste disposal companies face substantial hurdles
to collection of pharmaceutical wastes due to the DEA requirements" and
that "it is critical to coordinate these two important regulatory
initiatives by EPA and DEA, and require additional time for that
purpose."
Similarly, the Healthcare Distribution Management Association (HDMA)
says in Jan. 15 comments (see attached) that it "was pleased to see the
publication of [the EPA] proposal" but that it needs additional time to
"fully consider the interplay between EPA's proposal and other
regulations such as those of the Department of Transportation (DOT),
[DEA] and the Food and Drug Administration (FDA)."
The Northeast Waste Management Officials' Association (NEWMOA), which
represents state regulators, says in Jan. 15 comments (see attached)
that the comment period "extension would provide state environmental
agencies with adequate time to consider the effect that the proposal
would have upon currently regulated activities, exchange views and
information with other states, and prepare thoroughly considered
comments."
The American Nurses Association (ANA) praised the proposal in Jan. 8
comments (see attached) and was one of few commentators not to request
an extension of the comment deadline. "ANA concurs with the EPA's
proposal that adding certain pharmaceutical to the Universal Waste Rule
will indeed encourage and promote safer, more environmentally sound
methods of pharmaceutical disposal for health care facilities and other
similar industries," the group says. "ANA agrees that this new ruling
will facilitate consumer take-back programs for unwanted
pharmaceuticals."
2112009_dea
Deborah L. DeBiasi
Email: <A class=moz-txt-link-abbreviated href="mailto:dldebiasi@deq.virginia.gov">dldebiasi@deq.virginia.gov</A>
WEB site address: <A class=moz-txt-link-abbreviated href="http://www.deq.virginia.gov">www.deq.virginia.gov</A>
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
PPCPs, EDCs, and Microconstituents
Mail: P.O. Box 1105, Richmond, VA 23218 (NEW!)
Location: 629 E. Main Street, Richmond, VA 23219
PH: 804-698-4028
FAX: 804-698-4032
</PRE><PRE wrap=""><HR width="90%" SIZE=4>
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